Embolic protection device

ABSTRACT

An embolic protection filter. In some embodiments, the device includes an elongate shaft, a filter coupled to the shaft, and a proximal stop coupled to the shaft.

RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 10/331,380 filed Dec. 30, 2002.

FIELD OF THE INVENTION

The present invention pertains to intravascular filtering devices. Moreparticularly, the present invention pertains to devices for filteringembolic debris generated during intravascular medical interventions.

BACKGROUND

Heart and vascular disease are majors problem in the United States andthroughout the world. Conditions such as atherosclerosis result in bloodvessels becoming blocked or narrowed. This blockage can result in lackof oxygenation of the heart, which has significant consequences sincethe heart muscle must be well oxygenated in order to maintain its bloodpumping action.

Occluded, stenotic, or narrowed blood vessels may be treated with anumber of relatively non-invasive medical procedures includingpercutaneous transluminal angioplasty (PTA), percutaneous transluminalcoronary angioplasty (PTCA), and atherectomy. Angioplasty techniquestypically involve the use of a balloon catheter. The balloon catheter isadvanced over a guidewire such that the balloon is positioned adjacent astenotic lesion. The balloon is then inflated and the restriction of thevessel is opened. During an atherectomy procedure, the stenotic lesionmay be mechanically cut away from the blood vessel wall using anatherectomy catheter.

During angioplasty and atherectomy procedures, embolic debris can beseparated from the wall of the blood vessel. During angioplastyprocedures, stenotic debris may also break loose due to manipulation ofthe blood vessel. Because of this debris, a number of devices, termedembolic protection devices, have been developed to filter out thisdebris.

Embolic debris can also be generated when performing an intravascularprocedure at a location away from the heart. For example, engaging ortreating the renal artery may generate embolic debris.

BRIEF SUMMARY OF THE INVENTION

The present invention incorporates design and manufacturing refinementsto embolic protection devices. In some embodiments, a filter can becoupled to an elongate shaft. The shaft may comprise, for example, aguidewire. A proximal stop may be coupled to the shaft. The stop may beadapted and configured to essentially prevent a catheter from passingover the shaft distally beyond the stop and over the filter. The stopmay also be configured to release therapeutic drugs or other appropriatesubstances.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an embodiment of an embolic protectionfiltering device; and

FIG. 2 is a side view of another embodiment of an embolic protectionfiltering device.

DETAILED DESCRIPTION

The following description should be read with reference to the drawingswherein like reference numerals indicate like elements throughout theseveral views. The detailed description and drawings illustrate exampleembodiments of the claimed invention.

Intravascular medical procedures such as angioplasty or atherectomy cangenerate embolic debris. This debris can travel in the bloodstream andpossibly obstruct downstream vascular regions. FIG. 1 is a side view ofan embodiment of an embolic protection filtering device 10 that may beused to filter out embolic debris. Device 10 includes an elongate shaft12 having a filter 14 coupled thereto. A proximal stop 16 is coupled toshaft 12. Stop 16 is adapted and configured to stop a medical devicesuch as a therapeutic catheter from being advanced over shaft 14 beyondstop 16. Stop 16, thus, can prevent the medical device from beingadvanced distally over filer 14. A therapeutic catheter might be, forexample, an angioplasty catheter, stent deployment catheter, atherectomycatheter or other device.

The majority of the length of shaft 12 can generally have a constantoutside diameter, shown in FIG. 1 as OD1. OD1 is sized to allow othermedical devices to pass over shaft 12 as needed for any givenintervention. For example, an angioplasty or other catheter may bepassed over shaft 12 in order to perform a medical procedure. Accordingto this embodiment, shaft 12 can pass through a lumen disposed withinthe catheter. It can be appreciated that the size of OD1 can be variedfor different medical devices without departing from the spirit of theinvention. For example, OD1 may be about 0.014 inches or less. It isworthy of note that shaft 12 may include a region that tapers distally.The tapered region would, thus, have a decreased outside diameter.Generally, OD1 is the outside diameter of shaft 12 at locations proximalto the tapered region.

When using a typical guidewire/filter combinations, the potential existsthat a catheter may be advanced over or past the filter. If this occurs,the interventional device may engage the proximal end of the filter andclose it inadvertently and/or cause jamming of the devices together.Stop 16 has an outside diameter OD2 that is generally larger than OD1.In particular, OD2 of stop 16 is designed to be large enough tosubstantially prevent medical devices passing over shaft 12 from passingover and/or damaging filter 16. For example, OD2 may be about 0.026inches or less.

In general, a size relationship exists between OD1, OD2, and the insidediameter of a medical device to passed over shaft 12. Thus, the insidediameter of the medical device is sized to be larger than OD1 so thatthe medical device can be advanced over shaft 12. Additionally, OD2 issized to be larger than the inside diameter of the medical device sothat the medical device cannot pass stop 16. The relative sizes areconfigured so that OD2 is the largest (e.g., about 0.022 to 0.030inches), the inside diameter of the medical device is next largest(e.g., about 0.013 to 0.022 inches), and OD1 is the smallest (e.g.,about 0.010 to 0.016 inches). It can be appreciated that the actualsizes of these elements are not intended to limit the invention and canbe varied without altering the contemplated scope of the invention.

As stated above, stop 16 is coupled to shaft 12. Being coupled to shaft12 is understood to include being directly attached to shaft 12, beingattached to another device disposed adjacent shaft 12 (e.g., tube 18 asdescribed below), or any other suitable attachment. Stop 16 may becoupled to shaft 12 by any suitable technique. For example, stop 16 maybe coupled to shaft 12 by adhesive bonding, thermal bonding, soldering,etc. Stop 16 may be comprised of any suitable material. In someembodiments, stop 16 is comprised of a polymer, metal, or metal-polymercomposite. Alternatively, stop 16 may be comprised of or be plated witha radiopaque material. Radiopaque materials are understood to generallyproduce a relatively bright image on a fluoroscopy screen during amedical procedure. This relatively bright image aids the user of device10 in determining its location. Radiopaque materials include, but arenot limited to, gold, platinum, and plastic material loaded with aradiopaque filler.

In some embodiments, filter 14 is coupled to a tube 18 slidably disposedover shaft 12. Tube 18 is adapted and configured to allow filter 14 tobe advanced over shaft 12 to a desired location. Tube 18 may be held inposition by a first stop 20 (e.g., located near the distal end 22 ofshaft 12), and a second stop 24 (e.g., generally located proximally offirst stop 20). In some embodiments, stop 16 may be attached to tube 18.

Stop 16 and/or filter 14 may be adapted and configured to delivery apharmacological agent. For example, stop 16 may be coated withpharmacological agent such that stop 16 will elute or release the agent.Alternatively, the agent could be releasably encapsulated within stop 16so that the agent can be released over a period of time within thebloodstream. In another alternative, shaft 12 or another elongate shaftor other suitable element may physically alter stop 16 (e.g., bystimulation with force, electrical current, heat, etc.) so as to causethe agent to be released. Moreover, the physical means for releasing theagent may be controllable by the clinician so that the clinician canrelease the agent at any desired point in time.

A number of different pharmacological agents may be used in conjunctionwith stop 16. The therapeutic agent may be generally described as adrug, chemotherapeutic, antibiotic, etc. Additionally, thepharmacological agent may include anti-thrombogenic agents such asheparin, heparin derivatives, urokinase, and PPack (dextrophenylalanineproline arginine chloromethylketone); anti-proliferative agents such asenoxaprin, angiopeptin, or monoclonal antibodies capable of blockingsmooth muscle cell proliferation, hirudin, and acetylsalicylic acid;anti-inflammatory agents such as dexamethasone, prednisolone,corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine;antineoplastic/antiproliferative/anti-miotic agents such as paclitaxel,5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones,endostatin, angiostatin and thymidine kinase inhibitors; anestheticagents such as lidocaine, bupivacaine, and ropivacaine; anti-coagulantssuch as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containingcompound, heparin, antithrombin compounds, platelet receptorantagonists, anti-thrombin anticodies, anti-platelet receptorantibodies, aspirin, prostaglandin inhibitors, platelet inhibitors andtick antiplatelet peptides; vascular cell growth promotors such asgrowth factor inhibitors, growth factor receptor antagonists,transcriptional activators, and translational promotors; vascular cellgrowth inhibitors such as growth factor inhibitors, growth factorreceptor antagonists, transcriptional repressors, translationalrepressors, replication inhibitors, inhibitory antibodies, antibodiesdirected against growth factors, bifunctional molecules consisting of agrowth factor and a cytotoxin, bifunctional molecules consisting of anantibody and a cytotoxin; and cholesterol-lowering agents; vasodilatingagents; agents which interfere with endogenous vascoactive mechanisms;anti-sense DNA and RNA; and DNA coding for (and the correspondingproteins) anti-sense RNA, tRNA or rRNA to replace defective or deficientendogenous molecules, angiogenic factors including growth factors suchas acidic and basic fibroblast growth factors, vascular endothelialgrowth factor, epidermal growth factor, transforming growth factor α andβ, platelet-derived endothelial growth factor, platelet-derived growthfactor, tumor necrosis factor α, hepatocyte growth factor and insulinlike growth factor, cell cycle inhibitors including CD inhibitors,thymidine kinase (“TKt”) and other agents useful for interfering withcell proliferation, and the family of bone morphogenic proteins(“BMP's”) including BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 (Vgr-1), BMP-7(OP-1), BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15,BMP-16, “hedgehog” proteins.

Shaft 12 includes a proximal end 26 and distal end 22. Shaft 12 maycomprise any elongate medical device such as a guidewire, catheter(guide, diagnostic, or therapeutic), endoscopic device, arthroscopicdevice, etc. Shaft 12 can be made of any material suitable includingmetals, metal alloys, polymers, or the like, or combinations or mixturesthereof. Some examples of suitable metals and metal alloys includestainless steel, such as 304v stainless steel, nickel-titanium alloy,such as nitinol, nickel-chromium alloy, nickel-chromium-iron alloy,cobalt alloy, or the like, or other suitable material. The word nitinolwas coined by a group of researchers at the United States NavalOrdinance Laboratory (NOL) who were the first to observe the shapememory behavior of this material. The word nitinol is an acronymincluding the chemical symbol for nickel (Ni), the chemical symbol fortitanium (Ti), and an acronym identifying the Naval Ordinance Laboratory(NOL).

The entire shaft 12 can be made of the same material, or in someembodiments, can include portions or sections made of differentmaterials. In some embodiments, the material used to construct shaft 12is chosen to impart varying flexibility and stiffness characteristics todifferent portions of shaft 12. For example, the material compositionadjacent proximal end 26 of shaft 12 may be relatively stiff forpushability and torqueability, and the material composition adjacentdistal end 22 of shaft 12 may be relatively flexible by comparison forbetter lateral trackability and steerability. Relatively stiffmaterials, for example, may include straightened 304v stainless steelwire, and relatively flexible materials may include, for example, astraightened super elastic or linear elastic alloy (e.g.,nickel-titanium) wire. In addition, shaft 12 may generally taper neardistal end 22.

Shaft 12 may also include a distal tip 28. Distal tip 28 may comprise a“spring tip” or “floppy tip” similar to analogous tips known in the art.For example, distal tip 28 may comprise a coil or spring that helps makedistal end 22 generally atraumatic to blood vessel walls, body organs,and tissue when advancing device 10 through the vasculature.

Filter 14 and/or tube 18 may be disposed near distal end 22 of shaft 12.Filter 14 may generally comprise a number of configurations known tothose skilled in the appropriate art. Filter 14 may include a filterframe 30, a filter material 32 disposed over frame 30, and one or morestruts 34. In general, filter 14 operates between a first generallycollapsed configuration and a second generally expanded configurationfor collecting debris in a body lumen. Frame 30 may be comprised of a“self-expanding” shape-memory material such as nickel-titanium alloy (tobias filter 14 to be in the second expanded configuration). Filtermaterial 32 may be comprised of a polyurethane sheet and include atleast one opening that may be, for example, formed by known lasertechniques. The holes or openings are sized to allow blood flowtherethrough but restrict flow of debris or emboli floating in the bodylumen or cavity.

Strut 34 may be coupled to tube 18 (or shaft 12) by a coupling 36.Coupling 36 may be one or more windings of strut 34 about tube 18 (orshaft 12) or be a fitting disposed over an end of strut 34 to attach itto tube 18.

The position of stop 16 can be described as being generally adjacentfilter 16. In some embodiments, stop 16 is disposed proximally of a nosecone 38 coupled to tube 18. Stop 16 is generally located proximally offilter 14 but, as described above, could also be described as beingattached to shaft 12, attached to tube 18, etc.

FIG. 2 is a side view of another example embolic protection filteringdevice 110 that is essentially the same in form and function as device10 except that the position of stop 116 is altered. It can be seen inFIG. 2 that stop 16 is positioned just proximal of coupling 36. Thisposition may allow, for example, filter 114 to collapse to a lowerprofile. It can be appreciated that the precise location of stop 116 maybe altered to essentially any location proximal of the distal end offilter 114 without departing from the spirit of the invention. Forexample, stop 116 may be attached to shaft 12, attached to tube 18, etc.Stop 116 has an OD2 similar to stop 16 and is designed to be largeenough to substantially prevent medical devices passing over shaft 12from engaging the proximal end of the filter and close it inadvertentlyand/or cause jamming of the devices together.

From FIG. 2 it can also be seen that the dimensions of device 110 (ordevice 10) and components thereof may be altered. For example, filter114 has a shape that is more elongated than filter 14. In general, thelength of filter 14/114 (measured from the distal end to strut 34) mayrange from about 10 to 30 millimeters. Additionally, the length ofdistal tip 28 may be varied (e.g., between about 15-40 millimeters), thespacing between filter 14/114 and stop 16/116 may be varied (e.g.,between about 5 to 15 millimeters), the spacing between distal tip 28and first stop 20 may be varied (e.g., between about 0 to 5millimeters), and the spacing between the distal end of tip 28 and theproximal end (e.g., at the junction of filter 14/114 or at the junctionof frame 30 and strut 34) of filter 14/114 may be varied (e.g., betweenabout 45 and 60 millimeters). The shapes, lengths, and dimensions listedabove are provided as examples, and should not be interpreted to limitthe claimed invention.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of theinvention. The invention's scope is, of course, defined in the languagein which the appended claims are expressed.

1. (canceled)
 2. An embotic protection filtering device, comprising: anelongate shaft having a proximal end and a distal end; a medical devicedisposed on the elongate shaft and defining a lumen therethrough, saidlumen having a distal end; an embolic protection filter coupled to theelongate shaft; and a stop fixed to the elongate shaft proximate thefilter, wherein the distal end of the lumen defined by the medicaldevice is capable of passing at least partially over the filter and isnot capable of passing beyond the stop.
 3. The filtering device inaccordance with claim 2, wherein the filter includes a filter membraneand one or more struts, wherein the filter membrane is coupled to theshaft at a first location and the one or more struts are coupled to theshaft at a second location, the first location being distal of thesecond location.
 4. The filtering device in accordance with claim 2,wherein the stop is coupled to the shaft between the first location andthe second location.
 5. The filtering device in accordance with claim 2,wherein the filter includes one or more struts extending between thefilter membrane and the elongate shaft and coupled to the elongate shaftby a coupling member, and wherein the stop is coupled to the shaftproximally of the coupling member.
 6. The filtering device in accordancewith claim 2, wherein the stop is adapted and configured to release atherapeutic drug.
 7. The filtering device in accordance with claim 6,wherein the therapeutic drug includes an anti-coagulant.
 8. Thefiltering device in accordance with claim 2, wherein the stop has atransverse profile less than about 0.026 inches.
 9. The filtering devicein accordance with claim 2, wherein the elongate shaft includes aproximal region having a first outside diameter and a tapered region,and wherein the stop has a transverse profile larger in size than thefirst outside diameter.
 10. The filtering device in accordance withclaim 2, wherein the distal end of the lumen defined by the medicaldevice is capable of passing over the filter and is not capable ofpassing beyond the stop.
 11. The filtering device in accordance withclaim 2, wherein the filter is attached to a tube slidably disposed overthe shaft.
 12. The filtering device in accordance with claim 11, whereinthe stop is attached to the tube.
 13. An embolic protection filteringdevice, comprising: a shaft including a proximal region having a firstoutside diameter, a tapered region, and a distal end; a first stopcoupled to the shaft near the distal end; a second stop coupled to theshaft at a position proximal of the first stop; a filter assemblyslidably disposed over the shaft between the first and second stops, thefilter assembly including a tube and a filter membrane coupled to thetube; wherein the filter includes a nose cone, a filter frame, and oneor more struts extending between the filter frame and the tube, andwherein the one or more struts are coupled to the tube by a coupling; athird stop coupled to the tube between the nose cone and the coupling;and wherein the third stop has an outside diameter that is larger than adistal end of a lumen defined by a medical device slidable over theshaft, the distal end of said lumen being sized to pass over at least aportion of the filter and not to pass beyond the third stop.
 14. Thefiltering device in accordance with claim 13, wherein the distal end ofthe lumen is sized to pass over the filter and not to pass beyond thethird stop.
 15. The filtering device in accordance with claim 13,wherein third stop is adapted and configured to release a therapeuticdrug.
 16. The filtering device in accordance with claim 15, wherein thetherapeutic drug is an anti-coagulant.
 17. The filtering device inaccordance with claim 13, wherein the width of the third stop is lessthan about 0.026 inches.
 18. An embolic protection filtering device,comprising: an elongate shaft having a proximal end, a distal end and adistal portion adjacent to the distal end, the elongate shaft extendingthrough at least a portion of a lumen defined by a medical devicecapable of being advanced distally over the elongate shaft, said lumenhaving an inner diameter at its distal end; a first stop coupled to thedistal portion of the elongate shaft; a second stop coupled to thedistal portion of the elongate shaft distal of the first stop; a tubeslidably disposed over the distal portion of the elongate shaftintermediate the first stop and the second stop; an embolic protectionfilter coupled to the tube; and a third stop attached to the tube, saidthird stop having an outer diameter greater than the inner diameter ofthe lumen at its distal end such that the distal end of the lumen issized to pass over at least a portion of the filter and not to passbeyond the third stop.
 19. An embolic protection filtering device,comprising: an elongate shaft having a proximal end and a distal end; amedical device disposed on the elongate shaft, said medical devicedefining a lumen having a distalmost inner dimension; an embolicprotection filter coupled to the elongate shaft at a first location anda second location; and a stop fixed to the elongate shaft intermediatethe first location and the second location, the stop having an outerdimension larger than the distalmost inner dimension of the lumenthereby preventing the medical device from advancing relative to theelongate shaft beyond the stop, wherein the distalmost end of the lumenis sized to pass over at least a portion of the filter.